Attorney:
Jeffrey B. McIntyre
January 13, 2020
Last month, the Federal Circuit affirmed the District Court of Delaware's decision in Persion Pharmaceuticals v. Alvogen invalidating as obvious two Persion patents claiming methods of treating pain in patients with hepatic impairment (compromised liver functionality) using hydrocodone. Important to the Federal Circuit's decision was the concept of "inherency."... Read more
Attorney:
Lisa M. Mandrusiak
December 19, 2019
This week the Federal Circuit affirmed Amgen's win against Hospira with respect to Hospira's erythropoietin ("EPO") biosimilar—a drug used to increase red blood cell number—in a Delaware trial where Amgen's U.S. Patent No. 5,856,298 was found to be infringed and not invalid and Amgen was found to be entitled to $70 million for damages associated with its EPO drug Epogen®. Part of the appeal was also dedicated to examining the so-called Safe Harbor provision of 35 U.S.C. § 271(e)(1), where the Federal Circuit agreed with Amgen that Hospira manufactured at least 14 batches of the drug that were not protected by this provision. The Court's decision provides lessons in how companies should be careful to avoid stretching the bounds of the Safe Harbor provision... Read more
Attorney:
Richard D. Kelly
December 16, 2019
The Solicitor General (SG) was invited by the Supreme Court to provide comments on the certiorari petitions filed by Berkheimer and Hikma to review the Federal Circuit's 101 decisions adverse to them. The two briefs have numerous similarities including identifying the Court's decision in Bilski[1]as starting the patent eligibility confusion by not grounding its decision on interpreting the meaning of the 35 U..S.C. 101 terms "process, machine, manufacture, [and] composition of matter." The SG asserts that in Bilski the Court did not ground its decision on the stature terms but instead found three exceptions to be not required by the statutory text: laws of nature, physical phenomenon, and abstract ideas. While these concepts are found earlier Supreme Court decisions, Bilski represented the first time they were used independent of the statutory language or constitutional concept of the "useful arts." The SG then described Mayo[2] as continuing the Court's Bilski practice of not tying patent eligibility to any of the statutory or Constitutional language. Alice[3] characterized the Mayo decisional approach as a two step process.... Read more
Attorney:
Daniel J. Pereira, Ph.D.
October 11, 2019
The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) reversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably:... Read more
Attorney:
Richard D. Kelly
September 17, 2019
The doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test. The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel.... Read more
September 13, 2019
On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more
Attorney:
Daniel J. Pereira, Ph.D.
August 16, 2019
Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.... Read more
Attorney:
Richard D. Kelly
August 12, 2019
Every innovative pharma company faces the same challenge, how to delay the patent cliff. The existence of the "skinny viii" (21 U.S.C. § 355(j)(2)(A)(viii)) makes developing additional FDA approved indications unattractive from an LCM viewpoint. Such additional indications may allow for market expansion during the life of the patents protecting the original indication but offer no protection once those patents have expired. With a skinny viii the generic seeks approval only for indication with the earliest patent expiration. Formulation patents often provide scant protection because of the possibility of design arounds and being more easily challenged for invalidity since often the original patents are available as prior art... Read more
Attorney:
Daniel J. Pereira, Ph.D.
June 20, 2019
As all patent practitioners know, obviousness-type double patenting is a judicially created doctrine to prevent the unjust extension of patent term of follow on patents that are simply obvious variants of earlier patents. The doctrine is applied during prosecution with the USPTO and can be used to challenge the validity of issued patents in contested matters. 35 USC 121 also speaks to this issue in certain circumstances.<... Read more
Attorneys:
Richard D. Kelly and Yuki Onoe
June 17, 2019
During litigation or contested proceeding the patentee can point to commercial success of a product as evidence of non-obviousness of the claimed product. Although some work is necessary to show the nexus between the success in the market and the claimed invention, the evidence showing, for example, the product taking sales from competitive products could help the patentee's case.... Read more
Attorney:
J. Derek Mason, Ph.D., CLP
June 14, 2019
Radio great Paul Harvey would always leave listeners hanging during his broadcast, then return from a commercial with "the rest of the story". Previously, I wrote on the Federal Circuit ruling with respect to Tribal Immunity (https://www.oblon.com/publications/tribal-immunity-in-ipr-is-dealt-a-death-blow-by-the-federal-circuit). At the end of that article I stated: "I note, however, that in the final sentence of their analysis, the Federal Circuit explicitly stated that this decision did NOT address whether there is any reason to treat state sovereign immunity differently with respect to IPR proceedings. That will remain to be seen…"... Read more
Attorney:
Marina I. Miller, Ph.D.
May 28, 2019
Amneal Pharmaceuticals, LLC. ("Amneal") filed two petitions for inter partes review of claims 1–13 and 16–19 of U.S. Patent No. 9,034,376 ("the '376 patent") of Purdue Pharma L.P., P.F. Laboratories, Inc. and Purdue Pharmaceuticals L.P. ("Purdue"). In the petitions, Amneal argued that claims 1–13 and 16–19 were unpatentable for obviousness over the combinations of multiple prior art references including US 2002/0187192 A1 ("Joshi").... Read more
Attorney:
Richard D. Kelly
May 21, 2019
Often in writing applications there is a tendency to denigrate prior art techniques. This is not risk free as the patentee in Nuvo Pharmaceuticals (Ireland) v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. May 15, 2019) discovered.... Read more
Category: Patent Eligibility
Attorney:
Richard D. Kelly
March 26, 2019
The Federal Circuit on March 19 in Natural Alternatives Intl. v Creative Compounds LLC. reversed a district court's opinion finding Natural's patent claims to be patent ineligible. The district court's decision arose out of a motion for judgment on the pleadings filed by Creative.... Read more
Category: Federal Circuit
Attorney:
Yuki Onoe
February 24, 2019
The USPTO argues that a petitioner who has received a favorable final written decision in an IPR is estopped from reusing the same winning argument in a district court. If the Federal Circuit in BTG International Ltd. v. Amneal Pharmaceuticals LLC, agrees with the PTO, an ANDA sponsor would not take the risk of "winning" at the PTAB and would rather present the best argument in a district court.... Read more
Attorney:
Stephen G. Baxter, Ph.D.
February 11, 2019
In the recent decision, Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc., the Federal Circuit affirmed the PTAB's finding that Claims 8 to 13 of U.S. Reissue Patent 38,551 ("the '551 patent") owned by Research Corporation Technologies, Inc. ("RCT") are not unpatentable.... Read more
Attorney:
Vincent K. Shier, Ph.D.
January 28, 2019
Since the Federal Circuit’s decision in Wyeth v. Kappos, 591 F.3d 1364, 93 U.S.P.Q. 2d 1257 (Fed. Cir. 2010), aff’g, Wyeth v. Dudas, 580 F. Supp. 2d 138, 88 U.S.P.Q.2d 1538 (D.D.C. 2008), which held that the USPTO was improperly reducing patent term adjustment (PTA) by improperly calculating “overlapping” days of agency delay under 35 U.S.C. §154, the courts have been asked on numerous occasions to look at how the USPTO is calculating PTA. Not every case has been decided in favor of the challenger, but a fair amount has. In addition, the USPTO has identified several internal errors including not accounting for the IDS safe harbor under 37 C.F.R. §1.704(d). As such, patentees should be very mindful of this evolving and important provision of law.<... Read more
December 12, 2018
Since the Supreme Court's decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), there has been significant discussion on SAS's expected effect on estoppel for IPRs. Essentially universal opinion holds that estoppel will apply to all grounds raised in the IPR petition due to the all-or-nothing institution standard applied by the Patent Trial and Appeal Board ("PTAB") in response to SAS. Post-SAS, final written decisions in IPRs will address all grounds raised in the petition if at least one ground meets the standard for institution, thus making estoppel applicable to all petition grounds as grounds "that the petitioner raised … during that inter partes review" under 35 U.S.C. § 315(e).... Read more
Attorney:
Marina I. Miller, Ph.D.
December 3, 2018
Yeda Research and Development Co., Ltd. ("Yeda") is the assignee of three "Copaxone patents" that describe and claim COPAXONE® 40mg/mL (glatiramer acetate ("GA")), a treatment for relapsing-remitting multiple sclerosis ("RRMS"). For analyzing the obviousness of the Copaxone patents, a key limitation of the claims is the administration of a 40mg GA dose in three subcutaneous injections over seven days. The Patent and Trademark Appeal Board ("the Board") found (and the district court affirmed) that the prior art described all limitations of the claims except for the administration of 40mg GA 3x/week for seven days. However, the Board and the district court concluded that the claimed dosage regiment would have been obvious to a parson of skill in the art (POSITA). Yeda appealed both decisions.... Read more
Attorney:
Lisa M. Mandrusiak
November 30, 2018
Post grant reviews (PGRs) have proven to be more popular in the biotechnology space (TC 1600) than any other art unit, with 42—or 28.1%—of the PGRs filed to date classified as TC 1600 patents.[1] By way of comparison, TC 1600 makes up just 10.1% of all IPRs filed to date. Perhaps not surprisingly, PGRs are appealing for challengers of biotechnology patents because written description, enablement, and indefiniteness can all be raised, and these § 112 hurdles tend to be more challenging in the unpredictable arts of TC 1600. <... Read more
November 9, 2018
On Friday, November 2, 2018, the USPTO released its interim procedure for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (83 Fed. Reg. 55102 (Nov. 2, 2018); see text at: https://www.gpo.gov/fdsys/pkg/FR-2018-11-02/pdf/2018-24004.pdf). The interim procedure is effective from the date of the notice until the USPTO can update the patent term adjustment computer program and provide notice to the public that the program is updated.<... Read more
October 25, 2018
In a non-precedential decision issued by the U.S. Court of Appeals for the Federal Circuit (FWP IP APS v. Biogen MA, Inc., October 24, 2018, http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2109.Opinion.10-24-2018.pdf), the Court was tasked with reviewing a PTAB decision of an interference between the named parties.<... Read more
October 22, 2018
Teva Pharmaceutical USA, Inc. filed a Complaint and Motion for Preliminary Injunction in the U.S. District Court for the District of Columbia, alleging that the FDA's recent interpretation of the definition of "first applicant" is unlawful.... Read more
October 4, 2018
Motivation to combine and reasonable expectation of success are separate requirements that must be independently considered. By capitalizing on shortcomings in the petitions related to separately arguing these issues, Genentech was able to save two of three patents covering its blockbuster drug Herceptin®.... Read more
October 1, 2018
On September 24, 2018, the Solicitor General filed a motion to participate in oral argument as amicus curiae in Helsinn Healthcare v. Teva Pharmaceuticals. The U.S. government's interest in this case is obvious, as the decision would have a direct impact on how the USPTO examines and determines patentability of invention.... Read more
September 27, 2018
Hindsight bias is not simply an old chestnut argued ad infinitum in response to obviousness challenges. In this week's final written decision in IPR2017-01053 upholding all claims of U.S. Patent No. 8,268,299, the PTAB illustrated that—under the right circumstances—this argument can have teeth.... Read more
September 7, 2018
In an interesting, but non-precedential, decision from the Court of Appeals for the Federal Circuit (Supernus Pharmaceuticals, Inc. v TWI Pharmaceuticals, Inc et al (Fed. Cir., September 6, 2018-http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2513.Opinion.9-6-2018.pdf), the Court affirmed a decision from the U.S. District Court of New Jersey.... Read more
August 28, 2018
Over the summer, representatives introduced bills and amendments of interest to the pharmaceutical industry. First, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee that would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation and IPR, removing the option to use both. According to Senator Hatch, this Hatch-Waxman Integrity Act of 2018 would ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop lower-cost drugs, while at the same time providing innovators a period of exclusivity to recoup investments. Specifically, Senator Hatch commented that the availability of an alternative path to challenge patents through IPRs has threatened to upend the carefully-crafted Hatch-Waxman balance by enabling companies to put added litigation pressure on drug innovators above and beyond what Hatch-Waxman already provides.... Read more
July 30, 2018
Unlike many other countries, medical procedures are not per se unpatentable in the United States. This comes with a major caveat, specifically, 35 U.S.C. § 287(c) bars a medical procedure patent owner from enforcing the patent, by obtaining an injunction, monetary damages, and attorney fees, against a medical practitioner and a related health care entity based on the medical practitioner's performance of "a medical activity" (§ 287(c)(1)).... Read more
July 26, 2018
Earlier this month, the Federal Circuit issued an opinion in Jazz Pharmaceuticals v. Amneal Pharmaceuticals, upholding the PTAB's finding that certain materials related to the FDA regulatory review process for Xyrem® were sufficiently accessible to the public to constitute prior art to seven Jazz patents. These materials (the "ACA materials") were accessible via a link on the FDA website "where background material would be posted before the meeting, and the meeting minutes, transcript, and slides would be posted after the meeting."... Read more
July 26, 2018
The Federal Circuit issued its decision in Saint Regis Mohawk Tribe et al v. Mylan Pharmaceuticals Inc., et al (18-1638) on July 20, 2018. The central question addressed in the Federal Circuit's decision was whether the principal of sovereign immunity can be asserted by a patent owner to avoid their patent being subjected to the Inter Partes Review (IPR) process. The decision hinged on whether the IPR process is more akin to the civil litigation-like proceedings in adjudications before the Federal Maritime Commission in which state sovereign immunity was held to apply (Fed. Maritime Comm'n v. S.C. State Ports Auth., 535 U.S. 743, 754–56 (2002) ("FMC") or whether IPR is a traditional agency action in which it has been previously held that sovereign immunity does not typically apply (see, for example, Pauma v. NLRB, 888 F.3d 1066 (9th Cir. 2018); Karuk Tribe Hous. Auth., 260 F.3d at 1074; and Fed. Power Comm'n v. Tuscarora Indian Nation, 362 U.S. 99, 122 (1960)). It is important to note, however that there is no blanket rule that immunity does not apply in federal agency proceedings.... Read more
July 20, 2018
Endo Pharmaceuticals Solutions, Inc et al v. Custopharm, Inc. (Fed. Cir. July 13, 2018), is an appeal of a Delaware District Court rejecting Custopharm's validity challenge to patents covering Endo's Aveed® testosterone undecanoate (TU) intramuscular injection as part of a Paragraph IV ANDA filing.... Read more
May 17, 2018
On May 14, 2018, in Anacor v. Iancu, the Federal Circuit issued its opinion affirming the Board's invalidation of Anacor's tavaborole patent. The patent-in-suit, U.S. Patent No. 7,582,621, entitled "Boron-containing Small Molecules," is directed to the use of tavaborole to treat fungal infections. According to the disclosure, tavaborole can be used to treat a fungal infection known as onychomycosis, which is a nail disease responsible for approximately half of all nail disorders in humans. In an inter parties review, the Patent Trial and Appeal Board found all of the claims of the '621 patent unpatentable for obviousness. Anacor appealed with respect to only one of the claims and the Federal Circuit affirmed.... Read more
April 25, 2018
As re ported earlier, the Federal Circuit in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd. held that jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent. The Court also decided that an injunction is available to prevent inducement of infringement by a label.... Read more
April 9, 2018
In an attempt to understand the frequency of commercial success arguments and the likelihood of success of those arguments in TC 1600 IPRs, I used information from Oblon's TC 1600 library to compile statistics. As seen below, commercial success is not often relied upon, even for IPRs challenging patents covering named drugs. And, digging into the details of the cases reveals that—even when argued—commercial success very rarely wins the day.... Read more
February 12, 2018
In a recent IPR between Apotex v. OSI Pharmaceuticals, the PTAB relied on an OSI Securities and Exchange Commission (SEC) filing, a 10-K, to find the challenged claims unpatentable. (A 10-K is an SEC filing that provides a summary of a company's financial performance).... Read more
February 9, 2018
The PTAB recently reminded Petitioners of the importance of properly framing prior art arguments, upholding all claims of U.S. Patent No. 8,664,231 in IPR2016-01370 in a final written decision issued yesterday. The '231 patent—covering Rasuvo®, a rheumatoid arthritis drug containing high doses of methotrexate formulated for subcutaneous injection—was challenged based on two primary references: Grint (a U.S. patent) and Wyeth (a pharmaceutical label for conventional uses of methotrexate). The primary grounds for each reference were based on anticipation, and the PTAB determined that neither reference anticipated claim 1, the only independent claim of the '231 patent.... Read more